MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for IMPELLA 2.5 IMPELLA 2.5 EU 005040 manufactured by Abiomed Europe Gmbh.
[182037934]
The impella 2. 5 was returned and an investigation is underway. Upon completion, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182037935]
The complainant reported an (b)(6) male patient presenting for high risk percutaneous coronary intervention. The impella 2. 5 was selected for support. The device was inserted and used without issue. Upon successful hemodynamic support, the device was removed and the site was closed with a closure device. Soon after closure, the patient became hemodynamically unstable and required cardiopulmonary resuscitation. Two perforations in the apex of the ventricle were found, resulting in pericardial effusion. Surgical intervention was performed to resolve the injury and the patient has since recovered. Although no impella device malfunctions or deficiencies had occurred, the physician feels the impella still may have caused or contributed to this injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00364 |
| MDR Report Key | 9787769 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-07 |
| Date Facility Aware | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-07-17 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DR. |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA 2.5 |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-02-18 |
| Model Number | IMPELLA 2.5 EU |
| Catalog Number | 005040 |
| Lot Number | 1422971 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074 GM 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |